CREATININE STANDARD #65072— 510(k) K822477

Substantially Equivalent

Emd Chemicals, Inc.

FDA 510(k) clearance K822477 for CREATININE STANDARD #65072, Substantially Equivalent on 1982-09-17. Applicant: Emd Chemicals, Inc.. Device class: 2.

Clearance details

Applicant: Emd Chemicals, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1982-08-17
Decision date: 1982-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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